22,764 matching studies

Sponsor Condition of Interest
Trial of Social Work Services in Fracture Clinic Setting
Sheila Sprague Orthopaedic Fractures Socioeconomic Factors
Every year, many Canadians sustain a fracture that requires surgical treatment and results in a long recovery period. During this recovery period, patients may experience new or worsening mental health issues including depression, anxiety, or post-traumatic stress disorder. Additionally, patients m1 expand

Every year, many Canadians sustain a fracture that requires surgical treatment and results in a long recovery period. During this recovery period, patients may experience new or worsening mental health issues including depression, anxiety, or post-traumatic stress disorder. Additionally, patients may experience new or worsening social and financial problems, such as food and housing insecurity, due to being unable to work or take care of other daily responsibilities. Current care for fracture patients is focused on treating their physical injuries and overlooks these other challenges. To address this gap in care, the investigators propose having a social worker available in the fracture clinic to provide patients with support beyond the care of their physical injury. The investigators propose a trial of 2,000 patients to determine if social worker support improves recovery for patients after a serious fracture by reducing the number of times they return to the emergency room or urgent care centre. This trial will also determine if social work support improves patients' mental health, financial security, ability to work, and level of satisfaction with the care they receive, and whether it reduces the amount of opioid medication they use and number of missed visits during their recovery. Patients will be randomly assigned to receive either support from a social worker or usual care. For patients assigned to receive social worker support, the social worker will assess their individual needs and provide support, information, and referrals to social support services. The social worker will continue to support patients for up to one year after they join the trial. Patients will complete questionnaires at enrollment and at 6 weeks and 3, 6, 9, and 12 months after enrollment. If this trial shows that support from a social worker in the fracture clinic during their recovery period is beneficial to patients who have experienced a serious fracture requiring surgery, it has the potential to change care for patients who experience these potentially life-changing injuries.

Type: Interventional

Start Date: Oct 2025

open study

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2871
Merck Sharp & Dohme LLC Breast Neoplasms Triple Negative Breast Neoplasms HR Low-Positive/HER2-Negative Breast Neoplasms
Researchers are looking for new ways to treat types of breast cancer that are both: - High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment - Early-stage, which means the cancer is in the breast or the lymph nodes around the bre1 expand

Researchers are looking for new ways to treat types of breast cancer that are both: - High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment - Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: - Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy - Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Type: Interventional

Start Date: Jun 2025

open study

A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-011
Merck Sharp & Dohme LLC Malignant Melanoma
Researchers want to learn if V940 with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is1 expand

Researchers want to learn if V940 with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. V940 is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy. The goal of this study is to learn if people who receive V940 with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.

Type: Interventional

Start Date: May 2025

open study

AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard1
Boston Scientific Corporation Coronary Arterial Disease (CAD) de Novo Lesions in Native Coronary Arteries
AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting st1 expand

AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.

Type: Interventional

Start Date: Aug 2025

open study

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity o1
Eli Lilly and Company Hypertension
GZL2 is an independent study conducted under the GZPL master protocol. GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight. expand

GZL2 is an independent study conducted under the GZPL master protocol. GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

Type: Interventional

Start Date: Apr 2025

open study

Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma
H. Lee Moffitt Cancer Center and Research Institute Myeloma
The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defin1 expand

The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in the myeloma cells, benefit less from cilta-cel compared to myeloma patients without these characteristics.

Type: Interventional

Start Date: May 2025

open study

A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or W1
Eli Lilly and Company Healthy Overweight Obesity Type 2 Diabetes
The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body. Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up1 expand

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body. Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 9 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.

Type: Interventional

Start Date: Apr 2025

open study

A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors1
Merck Sharp & Dohme LLC Malignant Neoplasm
Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: - Hepatoblastoma is a common liver cancer in babies and very young children - RMS is a cancer that starts in muscle cells, often in a child's head and nec1 expand

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: - Hepatoblastoma is a common liver cancer in babies and very young children - RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs - Relapsed means the cancer came back after treatment - Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: - About the safety of HER3-DXd in children and if they tolerate it - What happens to HER3-DXd in children's bodies over time - If children who receive HER3-DXd have the cancer get smaller or go away

Type: Interventional

Start Date: May 2025

open study

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephrop1
Biogen Immunoglobulin A Nephropathy (IgAN)
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the eff1 expand

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: - Participants will be screened to check if they can join the study. - Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. - Neither the researchers nor the participants will know what the participants will receive. - Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. - Afterwards, participants will enter a follow-up period which will last 80 weeks. - In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

Type: Interventional

Start Date: May 2025

open study

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as Fi1
AstraZeneca Hepatocellular Carcinoma
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in pa1 expand

This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy

Type: Interventional

Start Date: May 2025

open study

A Study of GNTI-122 in Adults Recently Diagnosed With T1D
GentiBio, Inc Type 1 Diabetes (T1D) Type 1 Diabetes Mellitus
This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnose1 expand

This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety.

Type: Interventional

Start Date: Sep 2025

open study

A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Fun1
Eli Lilly and Company Liver Dysfunction Healthy
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants1 expand

The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants. The study will last up to approximately 9 weeks, excluding screening.

Type: Interventional

Start Date: Apr 2025

open study

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generali1
argenx New Onset Generalized Myasthenia Gravis (gMG)
The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each1 expand

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Type: Interventional

Start Date: Apr 2025

open study

A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
University of Alabama at Birmingham Type 2 Diabetes
The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period. expand

The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.

Type: Interventional

Start Date: Nov 2025

open study

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Apreo Health, Inc. COPD Emphysema
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREAT1 expand

The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?

Type: Interventional

Start Date: Jul 2025

open study

A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab S1
AbbVie Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Neoadjuvant
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous1 expand

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Type: Interventional

Start Date: Nov 2025

open study

Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptib1
Sir Mortimer B. Davis - Jewish General Hospital Breast Cancer Surgery
Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as to whether it is safe to do so. Relative to traditional or skin sparing1 expand

Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as to whether it is safe to do so. Relative to traditional or skin sparing mastectomy (SSM) techniques, nipple sparing mastectomy (NSM) is associated with improved psychosocial and sexual well-being and is significantly better for body image and reducing feelings of disfigurement. Despite this, guidelines have yet to endorse the use of NSM over other RRM techniques, stating that more data and longer follow-up are needed to confirm it as a safe and effective strategy in GPV carriers. As NSM was not routinely adopted in high-risk patient populations undergoing RRM before 2010, there has been little data to inform the long-term oncologic safety of NSM. Well-designed studies have reported low to negligible rates of subsequent breast cancer in BRCA1/2 carriers following NSM, but have been limited by short median follow-up of less than 3 years. The current study is designed to confirm, with longer follow-up, prior findings on the oncologic safety of NSM in unaffected BRCA1/2 carriers. The investigators will also expand data to other high-penetrance GPV carriers, including PALB2, CDH1, PTEN, and TP53, for whom there is little-to-no data on outcomes following RRM.

Type: Observational

Start Date: Feb 2025

open study

TECTONIC CAD IVL IDE Study
Abbott Medical Devices Coronary Artery Calcification Coronary Artery Disease Stenotic Coronary Lesion
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites expand

A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites

Type: Interventional

Start Date: Apr 2025

open study

A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease
Ono Pharmaceutical Co. Ltd Alzheimer Disease
This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with mild to moderate Alzheimer's disease (AD). This study aims to determine whether administering ONO-2020, an epigenetic regulator,1 expand

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with mild to moderate Alzheimer's disease (AD). This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition in individuals with Alzheimer's disease dementia.

Type: Interventional

Start Date: Apr 2025

open study

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Partici1
Janssen Research & Development, LLC Arthritis, Psoriatic
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA. expand

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Type: Interventional

Start Date: Feb 2025

open study

ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Ca1
Alliance for Clinical Trials in Oncology Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Early Stage Breast Carcinoma
This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemothera1 expand

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

Type: Interventional

Start Date: Sep 2025

open study

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate t1
Hoffmann-La Roche Atopic Dermatitis
The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD). expand

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Type: Interventional

Start Date: Apr 2025

open study

A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat M1
Merck Sharp & Dohme LLC Castration-Resistant Prostatic Cancer Metastasis
The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: - The safety of the study treatment1 expand

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: - The safety of the study treatment and if people tolerate it. - A safe dose level of I-DXd that can be used with other treatments. - Participant levels of prostate specific antigen (PSA) during treatment.

Type: Interventional

Start Date: Jul 2025

open study

Fertilo In Vitro Research Study and Trial
Gameto, Inc. In Vitro Maturation of Oocytes
The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will co1 expand

The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm. - Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours. - Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.

Type: Interventional

Start Date: Apr 2025

open study

Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic1
Optinose US Inc. Chronic Rhinosinusitis Without Nasal Polyps
This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number1 expand

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.

Type: Interventional

Start Date: Jul 2025

open study